A Study of BGM0504 Injection in Participants with Obesity or Overweight

A Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of BGM0504 Injection in Chinese Non-diabetes Participants with Overweight or Obese

This is a multicenter, randomized, double-blind, placebo-controlled phase III validation clinical study in Chinese adult non-diabetic overweight or obese Participants. The main purpose is to evaluate the clinical efficacy of BGM0504 injection for 36 weeks of administration as an adjunct to diet, exercise, and behavioral interventions in overweight or obese non-diabetic adults in China for weight management, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.

Study Overview

• Status: Recruiting
• Conditions: Overweight or Obesity
• Intervention / Treatment: Drug: 5 mg BGM0504 injection; Drug: 10 mg BGM0504 injection administered subcutaneously (SC) once a week; Drug: 15 mg BGM0504 injection; Drug: BGM0504 placebo

• Study Type: Interventional
• Enrollment (Estimated): 620
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ji,MD, chief physician, Peking University People's Hospital; Phone Number: 13910978815; Email: jiln@bjmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Chief physician, Peking University People's Hospital, PhD; Phone Number: 8613910978815; Email: jiln@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• A male or female aged 18 to 65 years inclusive at screening
• BMI≥28 kg/m², or 24.0≤BMI<28.0 kg/m² and previous diagnosis with at least one of the following comorbidities: i. Prediabetes (impaired fasting blood glucose and/or impaired glucose tolerance), hypertension, nonalcoholic fatty liver disease, or one or more of these; ii. Joint pain with weight bearing; iii. Dyspnea caused by obesity or obstructive sleep apnea syndrome
• Weight change < 5.0% (chief complaint) after diet and exercise control for at least 12 weeks before screening
• Female participants who are not pregnant or lactating. Female participants with childbearing potential and their partners should use highly effective, medically accepted contraception, will not have pregnancy and fertility plan, and refrain from donating ovum until one month after the end of the study

Exclusion Criteria:

• Diabetes mellitus
• Known to be allergic to 3 or more kinds of foods or medications, or allergic to GLP-1 agonist, or have a severe allergic disease (asthma, urticaria, eczematous dermatitis, etc.) at screening
• Has been treated with GLP-1 receptor agonists or similar drugs containing the same target, or drugs used for weight control in the three months prior to screening
• Secondary disease or drug-induced obesity, including : elevated cortisol (e.g. Cushing's syndrome), obesity due to pituitary and hypothalamic damage, obesity due to diet drug reduction/discontinuation, etc.;
• History of pancreatitis
• Have the currently uncontrolled thyroid diseases with stable treatment dose and clinically significant abnormal results of thyroid function test occurred at screening
• Previous history of moderate or severe depression, or PHQ-9 score ≥15, or history of other serious mental illness, or Any lifetime history of a suicide attempt

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5 mg BGM0504 injection	Drug: 5 mg BGM0504 injection; 5mg BGM0504 injection administered subcutaneously (SC) once a week.
Experimental: 10 mg BGM0504 injection	Drug: 10 mg BGM0504 injection administered subcutaneously (SC) once a week; 10mg BGM0504 injection administered subcutaneously (SC) once a week.
Experimental: 15 mg BGM0504 injection	Drug: 15 mg BGM0504 injection; 15mg BGM0504 injection administered subcutaneously (SC) once a week.
Placebo Comparator: BGM0504 placebo	Drug: BGM0504 placebo; BGM0504 placebo administered SC once a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change from Baseline in Body Weight	Change from baseline in body weight after 36 weeks of treatment	Baseline,Week 36
Percentage of Participants Who Achieve≥5% Body Weight Reduction	Percentage of Participants Who Achieve≥5% Body Weight Reduction	Baseline,Week 36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Body Weight	Percent Change from Baseline in Body Weight after 52weeks of treatment	Baseline, Week 52
Change From Baseline in Body Weight	Change from baseline in body weight	Baseline, Week36 and 52
Percentage of Participants Who Achieve≥5% Body Weight Reduction	Percentage of Participants Who Achieve≥5% Body Weight Reduction	Baseline, Week 36 and 52
Percentage of Participants Who Achieve≥10% Body Weight Reduction	Percentage of Participants Who Achieve≥10% Body Weight Reduction	Baseline, Week 36 and 52
Percentage of Participants Who Achieve≥15%Body Weight Reduction	Percentage of Participants Who Achieve≥15%Body Weight Reduction	Baseline, Week 36 and 52
Percentage of Participants Who Achieve≥20% Body Weight Reduction	Percentage of Participants Who Achieve≥20% Body Weight Reduction.	Baseline, Week 36 and 52
Change From Baseline in Waist Circumference	Change From Baseline in Waist Circumference after 52weeks of treatment.	Baseline, Week 36 and 52
Change From Baseline in Body Mass Index (BMI)	Change From Baseline in Body Mass Index (BMI) after 52weeks of treatment	Baseline, Week 36 and 52
Change From Baseline in Fasting Glucose	Change From Baseline in Fasting Glucose after 52weeks of treatment	Baseline, Week 36 and 52
Change From Baseline in Hemoglobin A1c (HbA1c)	Change From Baseline in Hemoglobin A1c (HbA1c) after 52weeks of treatment.	Baseline, Week 36 and 52

Collaborators and Investigators

• Sponsor: BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2024
• Primary Completion (Estimated): November 27, 2025
• Study Completion (Estimated): March 27, 2026

Study Registration Dates

• First Submitted: November 7, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Estimated): November 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: BGM0504-Ⅲ-WL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No